Amoxycillin and Clavulanic Acid
Consumer Medicine Information
What is in this leaflet?
Please read this leaflet carefully before you take GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets.
This leaflet answers some common questions about GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets. It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Sometimes new risks are found even when a medicine has been used for many years. Your doctor has weighed the expected benefits of you taking Amoxycillin clavulanic acid tablets against the risks this medicine could have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What are GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets used for?
Amoxycillin clavulanic acid tablets contain two active ingredients. One of these is a penicillin called amoxycillin and the other is clavulanic acid.
Amoxycillin clavulanic acid tablets belong to the penicillin group of antibiotics.
Amoxycillin clavulanic acid tablets are used to treat a wide range of infections caused by bacteria. These infections may affect the chest (bronchitis or pneumonia), bladder (cystitis), sinuses (sinusitis), the ears (otitis media) or the skin.
Amoxycillin clavulanic acid tablets work by killing the bacteria that cause these infections. Amoxycillin clavulanic acid tablets will not work against infections caused by viruses such as colds or the flu.
Your doctor may prescribe Amoxycillin clavulanic acid tablets for another use. If you want more information ask your doctor.
There is no evidence that Amoxycillin clavulanic acid tablets are addictive.
Before you take GA-Amclav 500/125 or GA-Amclav Forte875/125 tablets
Do not take Amoxycillin clavulanic acid tablets if:
- you have had an allergic reaction to penicillin or similar types of antibiotics (such as cephalosporins) or any of the ingredients contained in GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets.
The ingredients are listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty in breathing and swelling of the face or tongue. - you have previously experienced liver problems after taking Amoxycillin clavulanic acid tablets or any other medicines.
- the expiry date (EXP) printed on the pack has passed.
- the packaging is torn or shows signs of tampering.
- Do not give this medicine to anyone else; your doctor has prescribed it specifically for you and your condition.
- If you are not sure whether you should start taking Amoxycillin clavulanic acid tablets, talk to your doctor.
Tell your doctor if:
- you have ever had an allergic reaction (such as a rash) to antibiotics or other substances in the past.
- you are allergic to foods, dyes, preservatives or any other medicines.
- you have experienced liver problems after taking Amoxycillin clavulanic acid tablets or any other medicines.
- you have glandular fever (mononucleosis) or leukaemia.
- you are pregnant or think you may be pregnant or are breast-feeding.
Your doctor will discuss with you the possible risks and benefits of taking Amoxycillin clavulanic acid tablets during pregnancy or while you are breast-feeding. Amoxycillin clavulanic acid tablets can pass to your baby from breast milk. - you have any kidney or liver problems.
The dosage of Amoxycillin clavulanic acid tablets may need to be changed or you may need to be given an alternative medicine. - you have to test your urine for sugar.
Amoxycillin clavulanic acid tablets may affect the results of these tests. - Tell your doctor or pharmacist if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. In particular tell your doctor or pharmacist if you are taking any of the following:
– medicines used to treat gout (eg. probenecid or allopurinol).
– other antibiotics. These may interfere with the actions of Amoxycillin clavulanic acid tablets.
– the contraceptive pill. As with other antibiotics, you may need to use extra birth control methods (eg. condoms) while taking Amoxycillin clavulanic acid tablets. - Some medicines may affect the way other medicines work. Your doctor or pharmacist will be able to tell you what to do when taking Amoxycillin clavulanic acid tablets with other medicines.
How to take GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets
Follow the directions given to you by your doctor and pharmacist. Their directions may differ from the information contained in this leaflet.
Please read the direction label carefully. If you have any concerns about how to take this medicine talk to your doctor or pharmacist.
How much to take:
Take as directed by your doctor or pharmacist.
The usual dose of GA-Amclav 500/125 and GA-Amclav Forte 875/125 is one tablet twice a day.
How to take it:
Swallow the Amoxycillin clavulanic acid tablet with a full glass of water or other liquid. Amoxycillin clavulanic acid tablets can be broken in half, but should not be chewed.
Amoxycillin clavulanic acid tablets should be taken immediately before or with the first mouthful of food. Amoxycillin clavulanic acid tablets work best when taken this way. It may also help to prevent stomach upsets. However, Amoxycillin clavulanic acid tablets will still work if they are taken without food.
Space the doses as evenly as possible throughout the day. If you are taking Amoxycillin clavulanic acid tablets twice a day, take a dose about every twelve hours.
How long to take it for:
Keep taking Amoxycillin clavulanic acid tablets until the course is finished or for as long as your doctor tells you.
Do not stop taking Amoxycillin clavulanic acid tablets just because you feel better as the infection can return.
Do not stop taking, or change the dose without first checking with your doctor.
If you forget to take it:
If your next dose is due within six hours, skip the dose you missed and take your next dose at the normal time. Otherwise, take the missed dose as soon as you remember and then go back to taking your tablets as directed by your doctor.
Do not take a double dose to make up for the dose that you have missed.
Taking more than the prescribed dose can increase the chance of unwanted side-effects.
What do I do if I take too much? (Overdose)
Immediately telephone your doctor or Poisons Information Centre (telephone 131126) for advice, if you think you or anyone else may have taken too much, even if there are no signs of discomfort or poisoning.
Symptoms of overdose include mild to severe nausea, vomiting, cramps and diarrhoea.
If you are not sure what to do, contact your doctor, pharmacist or nearest hospital. Be sure to show the doctor the GA-Amclav 500/125 or GA-Amclav Forte 875/125 pack.
While you are taking GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets
Things you must do:
Take Amoxycillin clavulanic acid tablets exactly as your doctor has prescribed.
Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.
Tell your doctor, dentist or pharmacist you are taking Amoxycillin clavulanic acid tablets before starting any other medicines. Some medicines may affect the way other medicines work.
Tell your doctor if the symptoms of your infection become worse, or do not improve within a few days of starting Amoxycillin clavulanic acid tablets.
Things you must not do:
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use to treat any other complaints unless your doctor says to.
Things to be careful of:
Be careful drinking alcohol when you are taking Amoxycillin clavulanic acid tablets. Drinking alcohol while taking these tablets does not usually cause any problems. However, some people who drink alcohol while taking antibiotics similar to Amoxycillin clavulanic acid tablets have experienced adverse effects.
Be careful driving or operating machinery until you know how Amoxycillin clavulanic acid tablets affect you. Generally, these tablets do not cause any problems with your ability to drive a car or operate machinery. However, as with many other medicines, Amoxycillin clavulanic acid tablets may cause dizziness or tiredness in some people.
If you develop severe diarrhoea either when taking Amoxycillin clavulanic acid tablets or within several weeks after treatment, tell your doctor as soon as possible. Do not take any medication to stop the diarrhoea (eg. Lomotil or Imodium).
What are the side-effects?
Check with your doctor as soon as possible if you think you are experiencing any side-effects or allergic reactions due to taking Amoxycillin clavulanic acid tablets, even if the problem is not listed below. Like other medicines, Amoxycillin clavulanic acid can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.
Tell your doctor about any effect which is troublesome or ongoing.
MILD EFFECTS
Tell your doctor if you notice any of the following that are troublesome or ongoing:
- diarrhoea (several loose bowel movements per day), indigestion, pain in the stomach, feeling sick or being sick
- white, furry, sore tongue and mouth (oral thrush), abnormal taste
- soreness or itching of the vagina or vaginal discharge (vaginal thrush)
- headache, dizziness, tiredness, hot flushes
- tooth discolouration
MORE SERIOUS EFFECTS
Tell your doctor immediately if you notice any of the following during or after taking Amoxycillin clavulanic acid tablets:
- itching, rash
- dark urine or pale stools
- yellowing of the skin or eyes (jaundice)
- severe stomach cramps
- severe watery or bloody diarrhoea
- unusual bleeding or bruising
These may be symptoms of rare but serious side-effects and require urgent medical attention.
Stop taking Amoxycillin clavulanic acid tablets and immediately contact your doctor or go to the emergency department of your nearest hospital if any of the following happens:
- Wheezing, hives, severe skin reaction, fainting, swelling of limbs, face, lips, mouth or throat, difficulty swallowing or breathing.
These are signs of a severe allergic reaction to Amoxycillin clavulanic acid-RL tablets. - Allergy to these antibiotics is rare.
- Fits/seizures.
Rare events that have been reported with GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets include:
- inflammation of the bowel (colitis)
- inflammation of the liver (hepatitis)
- inflammation of the kidney (nephritis)
- blood disorders
Remember, you should tell your doctor or pharmacist as soon as possible if any of these, or any other unusual events or problems occur during or after treatment with GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets.
This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.
Tell your doctor or pharmacist if you notice any side-effects from your medicine which are not mentioned here.
Do not be alarmed by this list of possible side-effects. You may not experience any of them.
How do I store GA-Amclav 500/125 or GA-Amclav Forte 875/125 tablets?
Keep your tablets in the original pack until it is time to take them. If you take the tablets out of the pack they may not keep well.
Keep the pack in a cool dry place. Do not leave it in the car on a hot day. Do not store medicine in the bathroom or near a sink. Heat and dampness can destroy Amoxycillin clavulanic acid tablets.
Store all medicines out of the reach of children, such as in a locked cupboard.
If your doctor tells you to stop taking Amoxycillin clavulanic acid tablets or if the expiry date has passed, ask your pharmacist what to do with any tablets that are left over.
Product description
What they look like:
- GA-Amclav 500/125 tablets come as white to off white oval shaped tablets containing 500mg of amoxycillin and 125mg of clavulanic acid. The tablet is debossed with an ‘A’, a ‘C’ and a break line on one side and plain on the other side.
- GA-Amclav Forte 875/125 tablets come as white to off-white capsule shaped tablets containing 875mg of amoxycillin and 125mg of clavulanic acid. The tablet is marked with an ‘A’ and a’ C’ on both sides and a break line on one side.
Other ingredients:
- GA-Amclav 500/125 tablets contain the following inactive ingredients: magnesium stearate, sodium starch glycollate, silica colloidal anhydrous and microcrystalline cellulose. The coating on the tablets contains the colouring agent titanium dioxide, hypromellose 5cps, hypromellose 15 cps, Macrogol 4000, Macrogol 6000 and dimethicone 500.
- GA-Amclav Forte 875/125 tablets contain the following inactive ingredients: magnesium stearate, sodium starch glycollate, silica colloidal anhydrous and microcrystalline cellulose. The coating on the tablets contains the colouring agent titanium dioxide, hypromellose 5 & 15 cps, and macrogol 4000 and macrogol 6000.
GA-Amclav 500/125 and GA-Amclav Forte 875/125 tablets do not contain sucrose, lactose, gluten, tartrazine or any other azo dyes.
GA-Amclav 500/125 and GA-Amclav Forte 875/125 tablets are available only with a doctor’s prescription.
GA-Amclav 500/125 tablets come in blister packs of ten tablets.
(AUST R 199393).
GA-Amclav Forte 875/125 tablets come in blister packs of ten tablets. (AUST R 199394).
Supplier
Your GA-Amclav 500/125 and GA-Amclav Forte 875/125 tablets are supplied by:
www.ascentpharma.com.au
Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne VIC 3205
For further information telephone 1800 554 414
The information provided applies only to: GA-Amclav 500/125 and GA-Amclav Forte 875/125 tablets.
Prepared on August 2012
Version 1.0
Published by MIMS May 2013